1. Technical Field
Embodiments of the invention disclosed generally relate to systems and associated methods for ensuring compliance with regulation requiring qualified systems for operation. In particular, embodiments of the invention are directed to systems and methods for performing the majority or all of the qualifying of application programs and/or computer systems based on generic requirements and before identification of specific users of said application programs and/or computer systems.
2. Description of the Related Art
In the United States, the Food and Drug Administration (FDA) requires manufacturers to use validated systems. The FDA requires the “validation” of systems that track data important to, for example, the quality, safety, efficacy, and potency of a pharmaceutical product, such as clinical trial data, calibration data and scheduling, and maintenance scheduling, among others. Typically, validation consists of generating documented evidence which provides a high degree of confidence that the system will perform as expected and in a manner appropriate for its intended use. Usually, among other things, this involves verifying that the system has been developed based on documented procedures, has been installed as recommended by the manufacturer, and operates correctly as installed in a manner consistent with its intended use.
Currently software is not delivered pre-qualified because whether a system works correctly or not is determined at least partially by the manner in which it is installed and operated. Also, an otherwise qualified system may not be qualified for a particular use, or for use in a particular manner. As used here the term “system” means a combination of computer hardware and software components. A system, therefore, does not exist in its final form until hardware and/or software is installed at a customer site, on the customer's chosen hardware. As a result, a great amount of time and effort is spent upon each installation of a system to verify that the system meets the aforementioned criteria by qualifying the system after the software has been installed. Often, for software applications installed on a company network, the cost and duration of qualification of the computer system can exceed the cost of the software itself. The pharmaceutical industry as a whole spends significant resources in qualification even though many of the software packages used are common to many companies. This is increasing as the FDA becomes more familiar with software development and is applying stricter standards (reference 21 CFR Part 11). Often companies spend months qualifying a computer system at a high cost because such companies do not have in-house expertise in this area. This can be a challenge for small companies.
In addition to the effort required for the initial qualification, current qualification practices tend to lock companies into a fear of change, as each subsequent change (or upgrade) requires implementation of change control to ensure that a change is not detrimental to the operation of the system. This approach slows development and implementation of computerized tools that would greatly assist a company in implementing best practices to improve efficiency, accuracy, and productivity.
Usually, if a company desires to use a software application to support a critical function that would require validation, the company purchases the software from a software development firm and installs it on the company network or a stand-alone workstation.
Typical pharmaceutical software purchase and/or development projects generally include generating functional requirements, developing the software or purchasing over-the-counter software, testing the software during development (if applicable), installing the software at the customer location, validating the software (including installation qualification, operational qualification, and performance qualification as applicable), placing the system in use, and implementing change control.
Currently qualification of software generally involves a diverse project team for months from the inception of the project and costs tens of thousands of dollars to complete. Additional improvements to software can be burdensome even if beneficial, and changing to a different software package can be cost prohibitive. This prevents companies from using the best available software and may prevent smaller companies from using any software at all, since manual systems do not require qualification and may be easier to implement.
According to generally known practices in the industry, a customer/user must be involved virtually through the entire validation lifecycle of the project to ensure that the development appropriately meets the customer requirements. Additionally, the resulting system must be qualified in the installed configuration, which requires qualifying the system after purchasing it. This results in significant delays, costs incurred, and a reluctance to maintain the current revision of the software due to change control requirements.
Technology to date within the pharmaceutical industry has just begun considering qualification in the context of the Internet. The FDA has concluded that the Internet can be a “trustworthy and reliable communications pipeline for electronic records when certain measures are in place.” However, little has yet been proposed in the way of qualification solutions, except for the FDA indicating briefly that it “recommends use of digital signature technology and delivery acknowledgements (such as receipts, or separate confirmations executed apart from the Internet), in addition to validation of both the source and destination computer systems.”
It is known to use databases on the Internet, methods of ensuring that data transmitted on the Internet is accurate, and methods of performing a variety of Internet commerce related activities. However, the prior art is not cognizant of methods or systems applied to qualification of software/hardware system to achieve regulatory compliance, using the Internet, and wherein the software/hardware system is substantially qualified before a specific customer is identified.